Punctal plug with active agent

ABSTRACT

A method and apparatus for administering an active agent such as a medicine to a subject, uses an ocular implant such as a punctal plug, to which the active agent has been applied. The implant is installed at the eye of the subject for administering the active agent via tissues of the eye.

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates generally to the field of medicine, and inparticular to a new and useful method and apparatus for administering anactive agent, i.e. a medicine or medication, to a subject by transdermalor other surface absorption of the agent into the tissues in and aroundone or both eyes of the subject.

Punctal plugs are known which are made in suitable dimensions and ofsuitable materials to be removably inserted into the upper and/or lowerpunctal apertures or punctum of the eye, to block the opening and thecanaliculus communicating therewith, to prevent drainage of lacrimalfluid (tears). Such plugs are known to be made of suitable materials,such as polymers, for example polytetrafluorethylene (known by thetrademark TEFLON), or hydroxyethylmethacrylate (HEMA), hydrophilicpolymer, methyl methacrylate, or silicon, or even of stainless steel orother inert metal material.

It is also known to apply an active agent such as nicotine or a birthcontrol drug, to the inner surface of a patch which can be worn againstthe skin of a subject for transdermally administering the active agentto the subject.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a method and anapparatus for administering an active agent to a subject by applying theactive agent to at least one surface of an ocular implant such as apunctal plug, and installing the implant, e.g. inserting the punctalplug into a punctal aperture of the subject.

If the active agent or drug is meant for treating the tissues at thewalls of the canaliculus, for example, the drug is applied only to innersurfaces of the plug that are adapted to be in contact with or near thetissues of the canaliculus. The presence of tears is highly advantageousas a natural vehicle or carrier for the agent.

If the active agent or drug is meant for treating the eye itself, thedrug is applied only to outer surfaces of the implant or plug that areadapted to be outside the canaliculus. Here the presence of previouslysecreted tears or a tear pool is again advantageous as a natural vehicleor carrier for the agent.

Any or all surfaces of the implant may carry the active agent there thedesire is simply to have the agent enter the subjects blood stream viathe tissues in and around the eye.

The various features of novelty which characterize the invention arepointed out with particularity in the claims annexed to and forming apart of this disclosure. For a better understanding of the invention,its operating advantages and specific objects attained by its uses,reference is made to the accompanying drawings and descriptive matter inwhich preferred embodiments of the invention are illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is a schematic perspective view of an ocular implant in the formof a punctal plug according to the present invention; and

FIG. 2 is a perspective view of the area around the eye with otherembodiments of the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawing, FIG. 1 shows a punctal plug generallydesignated 10, having a stem 12 for insertion into the punctal aperture20 of an eye 24, and along the canaliculus 22 communicating with theaperture.

Plug 10 has a large stopper structure 14 connected to the outer end ofstem 12 for seating against the aperture 20 and sealing the canaliculus22 against the flow of tears onto the surface of the eye or eyeball 24.

FIG. 2, where the same of similar numerals are used to designatefunctionally similar parts, illustrates an eye 24 communicating withupper and lower canaliculi 22 a and 22 b, each with their our implant 10a and 10 b. Implant 10 a is a substantially cylindrical and solidcollagen plug that has been inserted into the upper punctum or tear duct20 a, to block the flow of tears while lower implant 10 b is hollow likea straw for the passage of tears. Implant 10 b includes a tapered shaftor stem 12 a with a flared open end 12 b immobilized at the lowerpunctum 20 b. A mushroom shaped inner stopper 14 a is formed at theopposite end of shaft 12 a for further setting the location of theimplant in the tear duct.

One of the embodiments illustrated in FIG. 2, e.g. the upper implant,may include a hollow core of the plug and another, e.g. the lower one,may include a hollow core filled with medication.

The active agent, e.g. a medicine or medication is applied, e.g. in oneor more bands of polymer material 16 at the inner end of the stem, or at18 on the outer end of the stopper 14 in the embodiment of FIG. 1, orover some or all of the surfaces of the implants of FIG. 2, orotherwise. Polymer that is absorbent to the agent is preferable so thatsufficient agent is present and available for discharge into thesurrounding tissues. A porous or absorbent material can alternatively beused to make up the entire plug or implant which can be saturated withthe active agent.

The hollow implant 10 b of FIG. 2 is also particularly useful in thatthe active agent can be applied to, or is otherwise available at theinner surface or interior of the implant, and is uniquely structured topass tears and thus administer the active agent to the tear stream in afashion that is controlled by the flow of tears which thus act as thecarrier for the agent. Unlike the usual tear stopping punctal plug, thehollow implant of the present invention provides a very different drugadministering method, scheme and structure.

Non-limiting examples of the active agents or medications which areappropriate for use with the invention include, for example only:topical prostaglandin derivatives such as latanoprost, travaprost andbimataprost used for the topical treatment of glaucoma. Also a treatmentfor corneal infections is appropriate using ciprofloxacin, moxifloxacinor gatifloxacin. Systemic medications useful for this invention arethose used for hypertension such as atenolol, nifedipine orhydrochlorothiazide. Any other chronic disease requiring chronicmedication could be used.

The treatment of allergic conjunctivitis and rhinitis are also goodapplications for the invention, e.g. using antihistamine andanti-allergy medication such as olopatadine and cromalyn sodium in or onthe implant.

The advantage is that there would be no need for chronic pill-taking ordrop taking. A once-per 3-6 month visit to the eye doctor would be allthat is needed. Also the issue of non-compliance, a major impediment tosuccessful treatment, would by avoided by the invention.

This list of active agents is not comprehensive in that many otheragents can be used with the present invention. For example, a treatmentfor dry eye by topical cyclosporin is particularly interesting foradministration by the present invention, but many other active agentscan also be administered using the method and apparatus of theinvention.

The invention is meant to embody all implants or devices which areimplanted into the eye-lid canalicular puncta of the naso-lacrimalsystem with the goal of delivering drug to the eye or to the body.

The implant is inserted into either the inferior (lower) or superior(upper) punctum or possibly both. The apparatus is constructed so as tohave a drug attached to one or both sides of the implant and anocclusive plug of some inert biocompatible material.

Depending on the desired therapy, the implant could be oriented in thepunctal canal to deliver the drug either to the tear lake and thus theeye, or to the nasolacrimal system and thus the body's systemiccirculation. The drawings illustrate only three embodiments of thepunctal plug or implant delivery system of the invention.

While a specific embodiment of the invention has been shown anddescribed in detail to illustrate the application of the principles ofthe invention, it will be understood that the invention may be embodiedotherwise without departing from such principles.

1-19. (canceled)
 20. A method for administering an active agent to asubject using a punctal plug, the method comprising: inserting thepunctal plug into a punctal aperture wherein the punctal plug is placedin a vertical portion of a canaliculus proximal to the punctal apertureof an eye of the subject, wherein the composition of the punctal plugcomprises: a) an active agent, and b) a polymer, wherein the shape ofthe punctal plug consists of a constant diameter cylinder.
 21. Themethod of claim 20, wherein the active agent is selected from the groupconsisting of topical prostaglandin; latanoprost; travoprost;bimatoprost; a medication for treatment of a corneal infection;ciprofloxacin; moxifloxacin; gatifloxacin; a systemic medication; amedication for treating hypertension; atenolol; nifedipine;hydrochlorothiazide; and a medication for treating allergicconjunctivitis.
 22. The method of claim 20, wherein the active agent iscyclosporine.
 23. The method of claim 20, wherein the active agent is amedication for treatment of dry eye.
 24. The method of claim 20, whereinthe active agent is a medication for the topical treatment of glaucomaor corneal infection.
 25. The method of claim 20, wherein the polymer isa hydrophilic polymer.
 26. The method of claim 20, wherein the polymeris porous or absorbent.
 27. The method of claim 20, wherein the activeagent is travoprost or a systemic medication.
 28. A punctal plugcomprising: a) an active agent, and b) a polymer, wherein the shape ofthe punctal plug consists of a constant diameter cylinder configured tobe inserted into a punctal aperture and placed in a vertical portion ofa canaliculus proximal to the punctal aperture of an eye.
 29. Thepunctal plug of claim 28, wherein the active agent is selected from thegroup consisting of topical prostaglandin; latanoprost; travoprost;bimatoprost; a medication for treatment of a corneal infection;ciprofloxacin; moxifloxacin; gatifloxacin; a systemic medication; amedication for treating hypertension; atenolol; nifedipine;hydrochlorothiazide; and a medication for treating allergicconjunctivitis
 30. The punctal plug of claim 28, wherein the activeagent is cyclosporine.
 31. The punctal plug of claim 28, wherein theactive agent is a medication for treatment of dry eye.
 32. The punctalplug of claim 28, wherein the active agent is a medication for thetopical treatment of glaucoma or corneal infection.
 33. The punctal plugof claim 28, wherein the polymer is a hydrophilic polymer.
 34. Thepunctal plug of claim 28, wherein the polymer is porous or absorbent.35. A punctal plug inserted into a punctal aperture and placed in avertical portion of a canaliculus proximal to the punctal aperture of aneye comprising: a) an active agent, and b) a polymer, wherein the shapeof the punctal plug consists of a constant diameter cylinder.
 36. Thepunctal plug of claim 35, wherein the active agent is selected from thegroup consisting of topical prostaglandin; latanoprost; travoprost;bimatoprost; a medication for treatment of a corneal infection;ciprofloxacin; moxifloxacin; gatifloxacin; a systemic medication; amedication for treating hypertension; atenolol; nifedipine;hydrochlorothiazide; and a medication for treating allergicconjunctivitis.
 37. The punctal plug of claim 35, wherein the activeagent is cyclosporine.
 38. The punctal plug of claim 35, wherein theactive agent is a medication for treatment of dry eye.
 39. The punctalplug of claim 35, wherein the active agent is a medication for thetopical treatment of glaucoma or corneal infection.
 40. The punctal plugof claim 35, wherein the polymer is a hydrophilic polymer.
 41. Thepunctal plug of claim 35, wherein the polymer is porous or absorbent.